Below is a link to the full video of FDA Commissioner Scott Gottlieb's press conference, where he shares the Agency's vision for the future regulation of tobacco products including electronic nicotine delivery systems (ENDs) and vapor products.
We highly recommend watching Commissioner Gottlieb's remarks in conjunction with FDA's press release (link below), to gain the most insight as to what FDA is intending to do.
FDA's announcement today is a significant shift in the government's approach to regulating tobacco products, including ENDs (electronic nicotine delivery systems).
Commissioner Gottlieb, among other things, announced today that FDA is creating a new and comprehensive approach "to regulate nicotine," in its efforts to reduce addiction, and simultaneously recognized the benefits of vapor technology as an alternative to cigarettes, which he said "are the most harmful form of nicotine delivery."
FDA made clear that it intends to explore the implementation of additional regulations via new rule making, intended to control the level of nicotine in tobacco products including cigarettes and vape products. FDA also made comments that it intends to study the effects of flavors, and possibly issue regulations regarding flavors. This is one point to see cause for concern.
Our attorneys are still analyzing today's comments, but believe the following are the most significant takeaways:
- No New Products: While recognizing the benefit of new technology and innovation, FDA remained firm that no new products introduced after August 8, 2016 are allowed. We believe there is an opportunity in future to change this, but as of today, the 8/8/2016 date still stands.
- Advanced Notices of Proposed Rule Making: FDA will issue 2 ANPRs. One ANPR will focus on the effects of flavors in attracting youth to vaping and if the flavors are helping smokers switch or quit. The other ANPR we can expect will focus on reducing the level of nicotine in cigarette products, but it's unclear as to whether or not this ANPR will include language seeking to regulate the amount of nicotine we as manufacturers can put in our e-liquid. Regarding these two issues:
- 1- Flavors: FDA will continue to study the effects of flavors, both on youth and adults. It's very possible that FDA will issue regulations that will attempt to ban certain flavors, graphics, artwork, and flavoring nomenclature at some point in the future, which it feels appeal to children. Engagement with FDA, the legislative branch and the White House is crucial.
- 2- Reduced-nicotine products: FDA will most likely issue an ANPR seeking to reduce nicotine in combustible products and vapor products to "non-addictive levels" and include nicotine restrictions on vapor products. It is possible such regulation will begin only on combustibles (traditional cigarettes), but remain prepared for vapor products to be included. Again, dialogue and engagement is very important.
While FDA's comments today are in fact a landmark step for the vape industry towards future progress, there is still much to be done.
Continued strategic and organized engagement with FDA, the public health community, legislators, and consumers remain as important as ever. Continued efforts in the courts, coupled with legislative reform, and meaningful dialogue with Congress, FDA and OMB, OIRA, and SBA will hopefully lead to further landmark days for the vapor industry!
But, as we have alluded to above, serious issues remain regarding the ability to introduce new technologies, the future use of characterizing flavors (flavor bans), and the level of nicotine allowed in vapor products.
Lost Art Liquids still holds firm to the belief that vapor products should not be regulated in the same manner as tobacco products.
We will continue to use our lawsuit as an avenue to attempt to make meaningful, lasting change in our industry.
We will also continue to support Congressman Duncan Hunter's bill, which seeks to repeal and replace the FDA's deeming regulations. Congressman Hunter's bill is important because it sets up a separate regulatory framework for vapor products.
In summary, today's announcement gives our industry some much needed time, but we must use our newfound time wisely. Now is NOT the time to sit back and relax, now is the time to convince more legislators and the public that we are #TechnologyNotTobacco!
If you have any questions or comments, please email us at INFO@LOSTARTLIQUIDS.COM